Author: Site Editor Publish Time: 2021-12-06 Origin: Site
(1) Preparation before production: ① Check whether the operation room, tools, containers, equipment, etc. have the site clearance qualification mark, and check whether they are within the validity period. Otherwise, the site clearance shall be carried out according to the site clearance standard procedure, and the site clearance qualification certificate shall be filled in after passing the inspection by QA personnel before entering the next step of operation; ② Select the equipment suitable for ointment preparation according to the requirements. The equipment shall be hung with "qualified" and "cleaned" signs, and the equipment condition shall be checked to ensure that the equipment is normal before use; ③ Check whether the water, electricity and steam supply are normal; ④ Check whether the preparation containers and tools are clean and dry. If necessary, disinfect the emulsification tank, oil phase tank, water phase tank, preparation containers and tools of the vacuum homogeneous emulsifier with 75% ethanol solution; ⑤ Fill in the material requisition according to the production order, receive the raw and auxiliary materials from the material preparation and weighing room, and carry out the next operation after checking the product name, batch number, specification, quantity and weight; ⑥ Before operation, check whether the heating, mixing, homogenization, vacuum pumping and other functions of the emulsifier are normal; ⑦ Hang the operation status flag to enter the preparation operation.
(2) Preparation operation: ① Preparation of oil phase Add oil phase raw materials and control the temperature at 70 ℃. When the oil phase begins to melt, start stirring until it is completely melted; ② Preparation of aqueous phase Put the aqueous phase raw materials into the prescribed amount of pure water, heat and stir to completely dissolve; ③ According to the properties of drugs, add a specific amount of drugs in the preparation of water phase, oil phase or emulsification operation; ④ Emulsification Maintain the temperature of the above oil phase and water phase, press the oil phase and water phase into the emulsifying tank of the vacuum emulsifying machine through the pipeline with filter screen, and start the functions of heating, vacuum, mixing and homogenization in turn according to the process. After emulsification, cool down, stop mixing and vacuum stand; ⑤ Standing After standing for 24 hours, weigh the cream and send it to the filling and sealing process to continue production.